AMITRIPTYLINE VIATRIS

What it is

Amitriptyline is a tricyclic antidepressant with sedative properties. Amitriptyline VIATRIS tablets contain 10 mg, 25 mg or 50 mg of amitriptyline hydrochloride as the active ingredient.

Approved indications

— Treatment of major depression. — Nocturnal enuresis where organic pathology has been excluded.

Dosing overview

For depression in outpatient adults, 75 mg a day in divided doses is usually satisfactory, and if necessary may be increased to a total of 150 mg a day. For hospitalised patients, 100 mg a day may be required initially and can be increased gradually to 200 mg a day if necessary. In elderly patients, lower dosages are recommended, and 50 mg daily may be satisfactory in those who may not tolerate higher doses. Maintenance dosage is usually from 50 to 100 mg per day. For enuresis, a dose of 10 mg at bedtime has been found effective in children under 6 years of age; children 6 to 10 years of age may receive 10 to 20 mg per day; and in the age group from 11 to 16, a dose of 25 to 50 mg at bedtime may be required.

Key safety warnings

The risk of suicide attempt is inherent in depression and may persist until significant remission occurs. Patients with depression may experience worsening of their depressive symptoms and emergence of suicidal ideation and behaviour, whether or not they are taking antidepressant medications. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of a course of treatment or at the time of dose changes. Pooled analyses of short-term placebo-controlled trials showed that antidepressant drugs increase the risk of suicidal thinking and behaviour in children, adolescents and young adults with major depressive disorder and other psychiatric disorders. The average risk of such events in patients treated with an antidepressant was 4%, compared with 2% of patients given placebo. Severe cutaneous adverse reactions including drug reaction with eosinophilia and systemic symptoms, which can be life-threatening or fatal, have been reported in association with amitriptyline treatment, with most of these reactions occurring within 2 to 6 weeks. Patients with cardiovascular disorders should be watched closely. Tricyclic antidepressant medicines, including amitriptyline hydrochloride, particularly when given in high doses, have been reported to produce arrhythmias, sinus tachycardia, and prolongation of the conduction time. Myocardial infarction and stroke have been reported with medicines of this class.

Contraindications

Amitriptyline is contraindicated in patients who have shown prior hypersensitivity to it. Amitriptyline should not be given concurrently with monoamine oxidase inhibitors, including selegiline. The combination of amitriptyline with a monoamine oxidase inhibitor has caused severe convulsions, hyperpyretic crises and death. Amitriptyline is contraindicated in patients taking cisapride due to the possibility of adverse cardiac interactions including prolongation of the QT interval, cardiac arrhythmias and conduction system disturbances. Amitriptyline is not recommended for use during the acute recovery phase following myocardial infarction.

Regulatory history

Amitriptyline VIATRIS amitriptyline hydrochloride tablets are registered on the Australian Register of Therapeutic Goods under AUST R 232796 (10 mg tablet), AUST R 232797 (25 mg tablet), and AUST R 232798 (50 mg tablet).